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Electronic Record Assimilation and Subsequent Eradication of Hepatitis C (ERASE-C)

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Stanford University

Status

Completed

Conditions

Hepatitis C
Liver Diseases

Treatments

Behavioral: Patient portal message

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04873609
eP46287

Details and patient eligibility

About

Given the disproportionately high risk of chronic hepatitis C virus (HCV) infection in the baby boomer cohort, population-based screening has been demonstrated cost effective. Compared to point-of-care testing, however, bulk health messages with coupled lab requisitions delivered directly to patients meeting screening criteria via patient portals could improve HCV screening at minimal cost.

Full description

The Centers for Disease Control and Prevention (CDC) and the United States Preventative Services Taskforce (USPSTF) recommend a one-time hepatitis C infection (HCV) screen in individuals born 1945-65 (baby boomer birth cohort) and in others with risk factors for infection. National adherence to this Grade B recommendation-carrying the same strength of evidence as mammography, and screening for depression, alcohol abuse, and type 2 diabetes-is estimated to be 13.8%. Efforts to increase screening and linkage to HCV care, and also to understand barriers to screening and linkage are therefore warranted.

One such intervention, direct-to-patient messages via electronic medical record (EMR), has been demonstrated to improve adherence in influenza and pneumococcal vaccination, colon cancer screening, immunosuppression after transplantation, among others, but has not been studied as a strategy to improve HCV screening rates within health systems.

Our institution, Stanford Health Care, comprises 86 distinct clinical sites with approximately 1.25 million outpatient visits per year. All clinical sites are linked with an EMR (Epic Systems Corp.) and patients are encouraged to opt-in to receive and send health-related messages through a secure internet and smartphone portal, MyHealth. Approximately 60% of patients at our institution are enrolled in MyHealth.

MyHealth additionally allows bulk-messaging of patients meeting specific characteristics, e.g. patients due for influenza vaccination. Bulk messages can be coupled with laboratory or radiology requisitions. Messages are delivered through the online portal, text message, e-mail, and/or smartphone application notification, depending on patient preference. Laboratory and radiology results are routed automatically to patients' primary care physicians for review.

The investigators propose to conduct a randomized study comparing the effectiveness of a direct-to-patient electronic health message on HCV screening coupled with a lab requisition, versus HCV screening initiated by primary care clinicians as part of routine clinical care alone.

Enrollment

1,600 patients

Sex

All

Ages

54 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • persons born between 1945-1965
  • having an activated patient portal to receive secure messages (MyHealth)
  • no prior HCV antibody test within our EHR (electronic health record), including externally accessible results

Exclusion criteria

  • documented HCV viral load in our EHR
  • diagnosis of chronic HCV in their problem list

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,600 participants in 4 patient groups

No primary care provider (PCP) appointment, No patient outreach
No Intervention group
Description:
400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening
No PCP appointment, Patient outreach
Active Comparator group
Description:
400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening
Treatment:
Behavioral: Patient portal message
PCP appointment, No patient outreach
No Intervention group
Description:
400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening
PCP appointment, Patient outreach
Active Comparator group
Description:
400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening
Treatment:
Behavioral: Patient portal message

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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